FDA Adverse Event
Malfunction
Summary report: N
SPECTRUM INFUSION PUMP
MDR report key: 3170904
·
Received May 23, 2013
Report
- Report Number
- 1314492-2013-00636
- Event Type
- Malfunction
- Date Received
- May 23, 2013
- Date of Event
- April 1, 2013
- Report Date
- April 24, 2013
- Manufacturer
- BAXTER HEALTHCARE CORPORATION
- Product Code
- FRN
- PMA / PMN Number
- K042121
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PR, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
MFR REF NO: (B)(4). THE DEVICE WAS NOT RETURNED OR EVALUATED BY BAXTER. IF THE DEVICE IS SENT IN AND EVALUATED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE PROVIDED. SEE SCANNED PAGE.
Description of Event or Problem · 1
IT WAS REPORTED THAT A SPECTRUM PUMP WAS DISPLAYING AN AIR-IN-LINE MESSAGE. NO FURTHER INFO WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 228215 | SPECTRUM INFUSION PUMP | INFUSION PUMP | FRN | BAXTER HEALTHCARE CORPORATION | 35700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |